MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-26 for CHROMID? MRSA SMART AGAR 413050 manufactured by Biom?rieux Sa.
[90352856]
A customer from (b)(6) notified biom? Rieux of observing false positive (b)(6) results when testing patient samples with biom? Rieux chromid? Smart (b)(6) agar (ref (b)(4), lot 1005898640). They reported multiple strains were affected, but the number of patients involved was not provided. The customer reported that patient samples were affected and that the wrong results were reported to the treating physician. This resulted in incorrectly putting the patients in isolation. The customer also reported delays of a minimum of 24 hours. Though chromid? (b)(6) smart agar (ref. (b)(4)) is not registered, marketed of distributed in the u. S. , a similar product chromid? (b)(6)agar (ref. (b)(4)) is registered in the u. S. Biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00316 |
| MDR Report Key | 6980160 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-26 |
| Date of Report | 2018-05-17 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? MRSA SMART AGAR |
| Generic Name | CHROMID? MRSA SMART AGAR |
| Product Code | JSO |
| Date Received | 2017-10-26 |
| Catalog Number | 413050 |
| Lot Number | 1005898640 |
| Device Expiration Date | 2017-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-26 |